Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029) (NCT NCT01245751)

NCT ID: NCT01245751

Last Updated: 2017-04-12

Results Overview

VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

600 participants

Primary outcome timeframe

Day 1 (Baseline) and Week 6 postvaccination

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Booster Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Part 1: Day 1 to Week 52 (1 Year) STARTED	201	199	100	100
Part 1: Day 1 to Week 52 (1 Year) Completed 42-day Postvaccination Period	201	199	100	100
Part 1: Day 1 to Week 52 (1 Year) COMPLETED	199	194	100	98
Part 1: Day 1 to Week 52 (1 Year) NOT COMPLETED	2	5	0	2
Part 2: Week 156 (3 Year) Visit STARTED	161	139	0	0
Part 2: Week 156 (3 Year) Visit COMPLETED	161	139	0	0
Part 2: Week 156 (3 Year) Visit NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Booster Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Part 1: Day 1 to Week 52 (1 Year) Death	2	1	0
Part 1: Day 1 to Week 52 (1 Year) Lost to Follow-up	0	0	2
Part 1: Day 1 to Week 52 (1 Year) Withdrawal by Subject	0	4	0

Baseline Characteristics

Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Booster Dose Participants ≥70 Years of Age n=201 Participants Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age n=199 Participants Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age n=100 Participants Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age n=100 Participants Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Total n=600 Participants Total of all reporting groups
Age, Continuous	77.1 years STANDARD_DEVIATION 4.5 • n=5 Participants	76.3 years STANDARD_DEVIATION 5.1 • n=7 Participants	64.1 years STANDARD_DEVIATION 3.1 • n=5 Participants	55.5 years STANDARD_DEVIATION 2.8 • n=4 Participants	71.1 years STANDARD_DEVIATION 9.4 • n=21 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	94 Participants n=7 Participants	65 Participants n=5 Participants	77 Participants n=4 Participants	343 Participants n=21 Participants
Sex: Female, Male Male	94 Participants n=5 Participants	105 Participants n=7 Participants	35 Participants n=5 Participants	23 Participants n=4 Participants	257 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 6 postvaccination

Population: Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only.

VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)

Outcome measures

Outcome measures
Measure	Group 1: Booster Dose Participants ≥70 Years of Age n=201 Participants Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age n=199 Participants Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) Day 1 (Baseline), n=201, 199	248.0 gpELISA Units/mL Interval 219.7 to 280.0	254.2 gpELISA Units/mL Interval 223.5 to 289.3	—	—
Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) Week 6 postvaccination, n=198, 195	389.1 gpELISA Units/mL Interval 351.4 to 430.8	368.6 gpELISA Units/mL Interval 330.5 to 411.6	—	—

PRIMARY outcome

Timeframe: Day 1 (Baseline) and Week 6 postvaccination

VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.

Outcome measures

Outcome measures
Measure	Group 1: Booster Dose Participants ≥70 Years of Age n=198 Participants Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers	1.5 Fold Rise Interval 1.4 to 1.6	—	—	—

SECONDARY outcome

Timeframe: Up to 42 days postvaccination

Population: Analysis included all vaccinated participants who had any safety follow-up

An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.

Outcome measures

Outcome measures
Measure	Group 1: Booster Dose Participants ≥70 Years of Age n=201 Participants Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age n=199 Participants Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age n=100 Participants Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age n=100 Participants Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
Number of Participants Reporting One or More Adverse Experiences Any Adverse Event	104 Participants	95 Participants	72 Participants	72 Participants
Number of Participants Reporting One or More Adverse Experiences Injection-site Adverse Event	68 Participants	61 Participants	56 Participants	57 Participants
Number of Participants Reporting One or More Adverse Experiences Non-Injection-site Adverse Event	66 Participants	57 Participants	34 Participants	38 Participants
Number of Participants Reporting One or More Adverse Experiences Serious Adverse Event	3 Participants	5 Participants	1 Participants	0 Participants
Number of Participants Reporting One or More Adverse Experiences Vaccine-related Serious Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Group 1: Booster Dose Participants ≥70 Years of Age

Serious events: 29 serious events

Other events: 76 other events

Deaths: 0 deaths

Group 2: First Dose Participants ≥70 Years of Age

Serious events: 29 serious events

Other events: 58 other events

Deaths: 0 deaths

Group 3: First Dose Participants ≥60 and <70 Years of Age

Serious events: 6 serious events

Other events: 61 other events

Deaths: 0 deaths

Group 4: First Dose Participants ≥50 and <60 Years of Age

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: Booster Dose Participants ≥70 Years of Age n=201 participants at risk Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 2: First Dose Participants ≥70 Years of Age n=199 participants at risk Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 3: First Dose Participants ≥60 and <70 Years of Age n=100 participants at risk Herpes zoster history-negative participants ≥60 and \<70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.	Group 4: First Dose Participants ≥50 and <60 Years of Age n=100 participants at risk Herpes zoster history-negative participants ≥50 and \<60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
General disorders Injection-site erythema	21.9% 44/201 • Number of events 44 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	23.6% 47/199 • Number of events 47 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	41.0% 41/100 • Number of events 41 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	40.0% 40/100 • Number of events 40 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
General disorders Injection-site pain	23.4% 47/201 • Number of events 47 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	14.1% 28/199 • Number of events 29 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	42.0% 42/100 • Number of events 46 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	48.0% 48/100 • Number of events 48 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
General disorders Injection-site pruritus	5.0% 10/201 • Number of events 10 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	4.5% 9/199 • Number of events 9 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	9.0% 9/100 • Number of events 9 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	11.0% 11/100 • Number of events 11 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
General disorders Injection-site swelling	15.4% 31/201 • Number of events 31 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	12.1% 24/199 • Number of events 24 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	29.0% 29/100 • Number of events 29 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	33.0% 33/100 • Number of events 33 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
Infections and infestations Nasopharyngitis	5.5% 11/201 • Number of events 11 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	1.0% 2/199 • Number of events 2 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	5.0% 5/100 • Number of events 5 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	7.0% 7/100 • Number of events 7 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
Nervous system disorders Headache	4.0% 8/201 • Number of events 11 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	2.0% 4/199 • Number of events 8 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	3.0% 3/100 • Number of events 3 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)	9.0% 9/100 • Number of events 13 • Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER